Circumferential walker

ABSTRACT

An orthopedic device in the form of a circumferential walker includes a first member (posterior shell) and a second member (dorsal shell) corresponding to the first member. An outsole or plantar shell portion is attached to, or formed on or with the posterior shell. An expansion joint is positioned in the posterior shell or dorsal shell to expand to accommodate larger sized lower legs. The dorsal and posterior shells may include flexible or resilient edge portions to reduce pressure points and to further accommodate users having larger sized lower legs. The dorsal shell also includes a flexible or resilient connecting portion to accommodate users having larger ankles and feet and to reduce or eliminate the formation of a pressure point along the dorsal shell. Quick-connecting buckle assemblies can be provided to allow a user to quickly don and doff the orthopedic device.

This application claims the benefit of U.S. Provisional Application No.61/071,747, filed May 15, 2008, U.S. Provisional Application No.61/071,829, filed May 20, 2008, and U.S. Provisional Application No.61/099,017, filed Sep. 22, 2008.

FIELD OF THE INVENTION

The present invention relates generally to the field of orthopedic orprosthetic devices and more specifically to a circumferential orthopedicdevice that provides ease of donning, doffing, and adjusting with thebenefits of circumferential or wrap-around support and stabilization ofthe supported limb. In particular, exemplary circumferential lower legwalkers are disclosed that provide support and stabilization to thelower leg, ankle, and foot with improved donning, removal, andtightening of the circumferential walkers around the lower leg.

BACKGROUND

It is common that people, especially physically active and frail elderlypeople, experience a variety of lower leg, ankle and foot injuries. Forexample, sprains to the calcaneofibular and anterior tabofibularligaments often afflict a number of professional and amateur athletes.Other injuries can include moderate to severe ankle sprains, stable footand ankle fractures or other trauma, such as surgery.

To aid in the proper healing and treatment of these and other lower legand foot injuries, or for post-operative and/or rehabilitation purposes,it is necessary that the affected areas, as well as the surroundingtissue, be stabilized and immobilized.

Physicians traditionally have treated, and still currently treat,injuries affecting lower leg extremities and the foot by fitting theinjured patient with the well-known, molded plaster or resin cast, whichis set around an inner cotton or gauze lining. The placement of thistype of cast around the lower leg is time consuming, heavy, and costly.Further, this type of cast must not come into contact with water, whichmakes patient bathing difficult and time consuming. Additionally, if thecast needs to be removed for any reason, for example inspection orphysical therapy, a whole new cast must be prepared and applied.

Alternatively, lower leg walkers provide stabilization and support ofthe lower leg, including the ankle and foot, such that at least partialmobility may be maintained while an injury to the lower leg, ankle,and/or foot is in the process of healing. Further, in contrast to themolded plaster or resin cast, a lower leg walker can be removed by thepatient in order to bathe or for inspection of the injured limb by aphysician or practitioner.

Existing wrap-around or circumferential walkers can be bulky anddifficult and time consuming to don and doff. In particular, numerousstraps must be properly threaded through retaining rings and each strapindividually tightened in order to properly support and immobilize thelimb.

Further, existing circumferential walkers do not provide a mechanism foraccommodating different sized lower legs, ankles, and feet of differentusers. Thus, many different sized walkers are needed to accommodatedifferent sized users.

Alternatively, existing walkers may be of the one size fits all type,such that the walkers are designed for an average sized lower leg,ankle, and foot, but do not provide a comfortable fit for users thathave larger or smaller than average lower legs, ankles, and feet.Particularly, hard edges and surfaces of existing walkers can causepressure points that can cause users pain and discomfort, and may alsocause injury to a user.

Accordingly, exemplary embodiments of a circumferential lower leg walkerthat alleviate or eliminate the above mentioned drawbacks are describedherein.

SUMMARY

The orthopedic device described herein may be, in exemplary embodiments,a lightweight, offloading, lower leg walker. It is also contemplatedthat other orthopedic devices may utilize similar configurations asdescribed below.

The exemplary embodiments of a lower leg walker described hereintypically take the form of a circumferential type walker, which providessupport and stabilization to the lower leg by surrounding the lower leg,ankle, and foot with an appropriate supporting superstructure. It willbe recognized that the features described herein may have applicabilityto other lower leg walker configurations or other types of orthopedicdevices.

In exemplary embodiments, various configurations of quick connecttightening mechanisms are utilized to provide quick and easy adjustmentof the walkers in order to provide the desired amount of support andstabilization to the lower leg.

Further exemplary embodiments of a lower leg walker described herein maytake the form of a hinged circumferential type walker, which providessupport and stabilization to the lower leg by surrounding the lower leg,ankle, and foot with an appropriate supporting superstructure. It willbe recognized that the features described herein may have applicabilityto other lower leg walker configurations or other types of prosthetic ororthopedic devices.

In the exemplary embodiments, various configurations of an adjustablehinge arrangement, expansion arrangements, and a quick connectingarrangement are utilized to provide quick and easy adjustment of thewalker in order to provide the desired amount of support andstabilization to the lower leg and to accommodate numerous differentusers or wearers having different sized lower legs, ankles, and feet.

For example, an orthopedic device may include a first member (posteriorshell) and a second member (dorsal shell) corresponding to the firstmember. An outsole portion may be attached or integrated with a plantarshell portion of the posterior shell. The outsole may include one ormore hinge projections configured to engage one or more of apredetermined number of correspondingly shaped receiving openings in atoe cover portion of the dorsal shell in order to provide an adjustablehinge mechanism for the orthopedic device.

The posterior shell may include wing portions extending along the medialand lateral sides thereof. A flexible or resilient expansion joint maybe positioned in the posterior of the posterior shell between the wingportions or between the wing portions and the posterior of the shell toprovide a mechanism to allow the wing portions to expand to accommodatelarger sized calves and lower legs. The expansion joint may also includeflexible or resilient edge portions that extend along the proximalterminal edges of the posterior shell wing portions to reduce thelikelihood of a pressure point or to further accommodate users havinglarger sized lower legs.

The dorsal shell may also include a flexible or resilient edge portionalong the proximal terminal edge thereof to reduce the likelihood of apressure point or to further accommodate users having larger sized lowerlegs. Alternatively, a living hinge may be formed along the edge portionof the dorsal shell to allow the edge of the dorsal shell to flex toaccommodate users having larger sized lower legs and to reduce oreliminate pressure points.

The dorsal shell may also include a flexible or resilient portion or ahinge positioned between a proximal and distal portion of the dorsalshell in order to accommodate users having larger ankles and feet and toreduce or eliminate the formation of a pressure point along the dorsalshell.

Quick-connecting buckle assemblies may be provided to allow a user toquickly don and doff the orthopedic device. The quick-connecting buckleassemblies may be utilized with traditional hook and loop fastenerstraps. The user need only adjust the straps at the time of first use(or infrequently to accommodate swelling or reduction of swelling oftissues), and henceforth, each donning and doffing of the orthopedicdevice can be achieved via the use of the quick-connecting buckleassemblies, thus eliminating time consuming adjustment of numerousstraps.

The numerous other advantages, features and functions of embodiments ofa circumferential walker having the features discussed herein willbecome readily apparent and better understood in view of the followingdescription and accompanying drawings. The following description is notintended to limit the scope of the orthopedic device, but instead merelyprovides exemplary embodiments for ease of understanding.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a front side perspective view of an embodiment of acircumferential walker according to the present disclosure;

FIG. 2 is a side view of the embodiment of FIG. 1;

FIG. 3 is an alternate side view of the embodiment of FIG. 1;

FIG. 4 is a partially exploded schematic view of the embodiment of FIG.1;

FIG. 5 is a schematic view of an alternate strap configuration for usewith the embodiment of FIG. 1;

FIG. 6 is a schematic view of an alternate strap configuration for usewith the embodiment of FIG. 1;

FIG. 7 is side perspective view of a variation of the embodiment of FIG.1 utilizing the multi-loop strap adjuster shown in FIG. 4;

FIG. 8 is a partial sectional view of one of the straps shown in FIG. 7;

FIG. 9 is a side perspective view of another variation of the embodimentof FIG. 1 utilizing an alternate quick connecting strap configuration;

FIG. 10 is a side perspective view of a locking element of FIG. 9;

FIG. 11 is a cross-sectional view along plane 11-11 of the lockingelement of FIG. 8;

FIG. 12 is a close-up isolated perspective view of a connecting assemblyof FIG. 9;

FIG. 13 is a perspective view of a strap of FIG. 9;

FIG. 14 is a perspective view of an embodiment of a hingedcircumferential walker in accordance with the present disclosure;

FIG. 15 is a perspective view of the walker of FIG. 14 with the strapsremoved for clarity;

FIG. 16 is an expanded perspective view of the dorsal and posteriorshells of the walker of FIGS. 14 and 15 with the straps removed;

FIG. 17 is a side view of the posterior shell shown in FIGS. 14 and 15with the straps removed;

FIG. 18 is a side cross-sectional view of the posterior shell shown inFIGS. 14 and 15 with the straps removed;

FIG. 19 is a partial side cross-sectional view of an embodiment of thehinge between the dorsal shell and posterior shell of the walker ofFIGS. 14 and 15;

FIG. 20 is a side view showing the hinge action between the dorsal shelland posterior shell of the walker of FIGS. 14 and 15 with the strapsremoved;

FIGS. 21 and 22 are left and right side views of the walker of FIG. 14showing the straps and buckle and strap retaining assemblies;

FIG. 23 is a rear view of the walker of FIGS. 14 and 15 with the strapsremoved;

FIG. 24 is a rear cross-sectional view of the walker of FIGS. 14 and 15with the straps removed;

FIG. 25 is a perspective view of a variation of the posterior shell ofFIG. 14;

FIG. 26 is a bottom view of the posterior shell of FIG. 25;

FIG. 27 is a perspective view showing the bladders and padding of avariation of the walker of FIG. 14;

FIG. 28 is a top view of the bladders of FIG. 27;

FIG. 29 is a side view of the posterior shell, bladders, and dorsalshell of the variation shown in FIG. 27;

FIG. 30 is a top view of a variation of the bladders shown in FIGS.27-28;

FIG. 31 is a perspective view of a further variation of the bladders foruse in a circumferential walker;

FIG. 32 is a top view of a variation of the bladders shown in FIG. 31;

FIG. 33 is a perspective view of a buckle assembly for use with thevarious embodiments of a walker described herein;

FIG. 34 is a perspective view of the buckle assembly of FIG. 33 shown inan open or release configuration;

FIG. 35 is a rear view of the buckle assembly shown in FIG. 33;

FIG. 36 is a close up view of an eyelet for use with the variousembodiments of a walker described herein to connect the buckle assemblyshown in FIGS. 33-35 thereto;

FIG. 37 is a partial rear view of a variation of a posterior shell andexpansion mechanism for use with a hinged circumferential walker inaccordance with the present disclosure;

FIG. 38 is a partial cross-sectional view of the posterior shell of FIG.37;

FIG. 39 is a partial front view of a variation of a dorsal shell, pumpassembly, and valve assembly for use with a hinged circumferentialwalker in accordance with the present disclosure;

FIG. 40 is a partial cross-sectional view of the dorsal shell of FIG.39;

FIG. 41 is a partial perspective view of another variation of a dorsalshell for use with a hinged circumferential walker in accordance withthe present disclosure;

FIG. 42 is a partial perspective view of a variation of a hinge for usewith a hinged circumferential walker in accordance with the presentdisclosure;

FIG. 43 is a partial perspective view of another variation of a hingefor use with a hinged circumferential walker in accordance with thepresent disclosure;

FIG. 44 is a partial cross-sectional view of another variation of ahinge for use with a hinged circumferential walker in accordance withthe present disclosure;

FIG. 45 is a partial perspective view of another variation of a hingefor use with a hinged circumferential walker in accordance with thepresent disclosure;

FIG. 46 is a partial perspective view of another variation of a hingefor use with a hinged circumferential walker in accordance with thepresent disclosure;

FIG. 47 is a partial perspective view of another variation of a hingefor use with a hinged circumferential walker in accordance with thepresent disclosure;

FIG. 48 is a partial cross-sectional view of the arrangement shown inFIG. 47;

FIG. 49 is a partial perspective view of another variation of a hingefor use with a hinged circumferential walker in accordance with thepresent disclosure;

FIG. 50 is a partial cross-sectional view of the arrangement shown inFIG. 49;

FIG. 51 is a partial cross-sectional side view of another variation of ahinge for use with a hinged circumferential walker in accordance withthe present disclosure;

FIG. 52 is a partial cross-sectional side view of another variation of ahinge for use with a hinged circumferential walker in accordance withthe present disclosure;

FIG. 53 is an expanded partial cross-sectional side view of a variationof the hinge shown in FIG. 52;

FIG. 54 is a perspective view of another embodiment of a circumferentialwalker in accordance with the present disclosure;

FIG. 55 is an expanded view of the components of the circumferentialwalker shown in FIG. 54;

FIG. 56 is a perspective view showing a strapping configuration for usewith the circumferential walker shown in FIG. 54;

FIG. 57 is a side view of the posterior and plantar shell components ofthe circumferential walker shown in FIG. 54;

FIG. 58 is a rear view of the posterior and plantar shell components ofthe circumferential walker shown in FIG. 54;

FIG. 59 is a front view of the posterior and plantar shell components ofthe circumferential walker shown in FIG. 54;

FIG. 60 is a rear view of the dorsal shell component of thecircumferential walker shown in FIG. 54;

FIG. 61 is a front view of a pump assembly for use with thecircumferential walker shown in FIG. 54;

FIG. 62 is a cross-sectional view of the pump assembly shown in FIG. 61;

FIG. 63 is a front view of a liner for use with the circumferentialwalker shown in FIG. 54.

It should be noted that the drawing figures are not necessarily drawn toscale, but instead are drawn to provide a better understanding of thecomponents thereof, and are not intended to be limiting in scope, butrather to provide exemplary illustrations. It should further be notedthat the figures illustrate exemplary embodiments of a circumferentialwalker and the components thereof, and in no way limit the structures orconfigurations of a circumferential walker and components thereofaccording to the present disclosure.

DETAILED DESCRIPTION A. Environment and Context

Exemplary embodiments of an orthopedic device are provided for use instabilizing and supporting the lower leg, foot, and ankle. Features thatare provided on one side of the device can easily be provided on theother side of the device. In this manner, it is intended that theexemplary embodiments of the orthopedic device described herein may beused on either right or left lower legs, with any appropriatereconfiguration of components that is deemed necessary for the properfit and function of the device for the purpose of supporting andstabilizing either the left or right lower leg.

In the exemplary embodiments of the orthopedic device described herein,quick release strap mechanisms may be used to provide ease of tighteningthe device. Exemplary quick release strap mechanisms are described inU.S. Pat. No. 7,198,610, granted April 2007, commonly owned, and hereinincorporated in the entirety by reference.

The exemplary embodiments of the disclosure are adapted for supportingand stabilizing the lower leg of human beings, and may be dimensioned toaccommodate different types, shapes and sizes of human joints andappendages.

Exemplary materials and configurations for components of the orthopedicdevice, such as sole portions and shell portions, are described indetail in U.S. Pat. Nos. 5,078,128, granted January 1992, 5,329,705,granted July 1994, 5,378,223, granted Jan. 3, 1995, 5,464,385, grantedNovember 1995, and 5,761,834, granted June 1998, all assigned to RoyceMedical Co. and all incorporated herein in the entirety by reference.Additional exemplary configurations and materials are described indetail in U.S. Pat. No. 7,303,538, granted December 2007, assigned toÖssur hf, and incorporated herein in the entirety by reference.

For further ease of understanding the exemplary embodiments of anorthopedic device as disclosed herein, a description of a few terms isnecessary. As used herein, the term “dorsal” has its ordinary meaningand refers to the top surfaces of the foot, ankle and foreleg or shin.As used herein, the term “plantar” has its ordinary meaning and refersto a bottom surface, such as the bottom of a foot. As used herein, theterm “proximal” has its ordinary meaning and refers to a location thatis closer to the heart than another location. Likewise, the term“distal” has its ordinary meaning and refers to a location that isfurther from the heart than another location. The term “posterior” alsohas its ordinary meaning and refers to a location that is behind or tothe rear of another location. Lastly, the term “anterior” has itsordinary meaning and refers to a location that is ahead of or to thefront of another location.

The terms “rigid,” “flexible,” and “resilient” may be used herein todistinguish characteristics of portions of certain features of theorthopedic device. The term “rigid” is intended to denote that anelement of the device is generally devoid of flexibility. Within thecontext of support members or shells that are “rigid,” it is intended toindicate that they do not lose their overall shape when force isapplied, and in fact they may break if bent with sufficient force. Onthe other hand, the term “flexible” is intended to denote that featuresare capable of repeated bending such that the features may be bent intoretained shapes or the features do not retain a general shape, butcontinuously deform when force is applied. The term “resilient” is usedto qualify such flexible features as generally returning to an initialgeneral shape without permanent deformation. As for the term“semi-rigid,” this term is used to connote properties of support membersor shells that provide support and are free-standing, however suchsupport members or shells may have some degree of flexibility orresiliency.

B. Detailed Description of Various Embodiments of a CircumferentialWalker

An exemplary embodiment of a circumferential lower leg walker 300 isshown in FIGS. 1-3. As can be seen from the figures, this embodimentincludes complementary dorsal 302 and posterior 304 shells that areselectively engageable with each other in order to provide easy accessto the interior of the device for ease of donning and doffing thedevice, in particular for donning and doffing the device onto an injuredlimb.

The walker 300 is configured in an essentially two-piece or one-piececonstruction to provide a sleek and low profile device for use instabilizing and supporting the lower leg and includes quick connecttightening mechanisms that provide tightening of the walker about thelower leg. Numerous advantages are obtained from such a configuration,such as lower weight, and less opportunity for the device to catch onexternal objects or clothing. Any weight savings will be a substantialbenefit, as a user must swing the mass of the walker, along with theleg, through the gait cycle. Additionally, the ease with which thetightening mechanisms tighten the walker will aid users who may havetrouble manipulating numerous and more complicated strap arrangementswhich require individual straps to be threaded through D-rings or othersimilar retention members. In particular, elderly or infirm persons willbe able to properly tighten the walker with ease.

The walker 300 includes a semi-rigid, or substantially rigid shellconfiguration that is formed to support and surround the lower leg,foot, and ankle of a user. The shell configuration can extend from thefoot and ankle up along the shin and tibia of the lower leg to a desiredpoint below the knee joint. Exemplary suitable materials for forming theshells can include metals, such as aluminum, carbon, compositematerials, such as carbon fiber/epoxy composites, glass fiber/epoxycomposites, or suitable plastic materials, such as thermoplastic orthermosetting polymers, fiber reinforced plastic, molded chopped fibers,or any other suitable material. Other exemplary materials include, butare not limited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters.

The shell configuration includes a unitary dorsal shell 302, a posteriorshell 304, and side shell portions 310 extending along the lateral andmedial sides of an outsole 312. The side shell portions 310 may extendaround the anterior of the walker 300 to define a toe protector portion.The outsole 312 can be formed with suitable tread or other frictionenhancing characteristics, and to provide the appropriate rocker soletype response associated with lower leg walkers. Any suitable materialmay be utilized to form the outsole 312.

In order to further reduce the weight of the walker 300, and/or toprovide ventilation, material can be removed from areas of the shellportions to provide clearance holes 314. The clearance holes 314 can beformed in any of the shell portions and have any suitable size and/orshape.

In a variation, some or all of the clearance holes can be filled with aliner or spacer fabric to provide aerated cushioning for the foot withinthe walker. Exemplary spacer materials are described in detail in U.S.publication nos. 2006/0135902, published June 2006, and 2007/0185425,published August 2007, both incorporated herein in the entirety byreference. Such a spacer fabric can provide additional comfort and aproper fit of the walker 1.

In the exemplary configuration of the walker 300 shown in FIGS. 1-3,each of the dorsal and posterior shells 302, 304 includes wing portions306, 308 that extend from the respective shell portions towards theopposed shell portion. The wing portions 306, 308 wrap around the leg inorder to enclose and support the leg. The dorsal shell wing portions 306extend generally towards the posterior of the walker 300 and theposterior shell wing portions 308 generally extend towards the anteriorof the walker 300, such that corresponding dorsal and posterior wingportions generally overlap each other when the shells are broughttogether in a closed configuration. The wing portions 306, 308 can alsoserve as anchor points for quick connect straps.

As can be seen in FIGS. 1-4 eyelets 316 are formed in the wing portions308 of the posterior shell 304 and in the side shell portions 310 forselectively receiving and retaining a protruding portion of a strap 320or buckle assembly 322. The eyelets 316 have a larger sized section forreceiving a head 326 of a protruding portion 324 of a strap or buckleassembly, and a reduced size section that forms a seat 318. The seat 318can be in the form of a slot for engaging a reduced size section 328 ofa protruding portion 324 of a strap or buckle assembly.

The buckle assemblies 322 can be constructed in a similar configurationand function in a similar manner as described in U.S. Pat. No.7,198,610, incorporated by reference above.

As can be seen in particular in FIGS. 1-4, one end of a strap 320 isselectively securable to the posterior shell 304 via engagement of aprotruding portion 324 on the strap end with an eyelet 316 and seat 318formed in the dorsal shell. A similar protruding portion 324 is formedon a buckle assembly 322 for selective engagement with an eyelet 316 andseat 318 formed in the opposed side of the posterior shell 304. Multipleeyelets 316 can be formed along the posterior shell 304 and/or the sideshell portions 310 for either use with additional straps 320 or toprovide alternative locations for the existing straps 320. Exemplaryconnectors and receiver portions are described in detail in U.S.publication nos. 2006/0135902, published June 2006, and 2007/0185425,published August 2007, both previously incorporated herein by reference.It will be recognized that in place of the protruding portion andeyelet, other suitable connection mechanisms, such as snap fasteners orhook and loop fasteners, can be utilized.

The second end of the strap 320 includes a hook portion 332 and a loopportion 334 for selective engagement with each other in a mannerunderstood by a skilled artisan. Specifically, the hook portion 332 andthe loop portion 334 are configured such that the hooks of the hookportion 332 can releasably engage the loops of the loop portion 334.Thus, the second end of the strap 320 can be inserted through areceiving loop 330 on the buckle assembly 322 and folded over andreleasably secured to itself in order to set the strap length.

As an alternative to the hook 332 and loop 334 portions, a multi-loopstrap adjuster 342, shown in isolation in FIG. 4, and in FIGS. 7 and 8,can be used to provide the desired length adjustment of the straps.

The setting of the strap length is done with both the strap 320 and thebuckle assembly 322 engaged with the respective seats 318 and the buckleclosed. In this manner, the length of the strap need only be set once,and from this initial setting, the strap can be tightened and loosenedvia opening and closing of the buckle assembly 322, and/or disengagingthe protruding portions 324 of the strap 320 and/or buckle assembly 322from the respective seat 318 and/or eyelet 316. Thus, a quick adjustingstrapping system is achieved that allows for quick tightening andloosening of the straps for entry and removal of the lower leg, ankle,and foot from the walker 300.

As shown in FIGS. 1-3, at least two straps 320 are arranged to crossfrom opposed sides of the posterior shell 304 over the dorsal shell 302for bringing the two shells closer together for tightening the walkeraround the lower leg, ankle, and foot.

An additional strap 320, having a slightly different configuration, isshown in FIGS. 1-4 as crossing over the dorsal aspect of the foot anddorsal shell 302 in the region of the toes of the foot.

The strap 320 in the toe region of the foot is similar to the otherstraps, with the exception of an additional eyelet 316 and seat 318formed in a connecting element 336. The protruding portion 324 of thebuckle assembly 322 is selectively engaged with the eyelet 316 and seat318 formed in the connecting element 336 to provide an additional quickrelease connection to aid with tightening and loosening of the straps.It will be recognized that any of the disclosed strap configurations canbe substituted for any other disclosed strap configuration. It will alsobe recognized that the eyelets 316 and the protruding portions 324 canall be made to be interchangeably sized such that the orientation of thestraps 320 can be alternated from a leftward to a rightward orientation,and vice versa.

In a variation shown in FIG. 5, in place of either the hook 332 and loop334 portions or the multi-loop strap adjuster 342, a manual or automaticself winding element 338 can be provided in order to take up excessstrap length prior to closing the buckle assembly 322. Such an automaticself winding mechanism can include a spring loaded element that istensioned to draw in the excess strap length prior to closing the buckleassembly 322. In this manner, the additional step of manually adjustingthe strap length, as described above, can be eliminated, thus furthereasing the donning and doffing of the walker, and the tightening of thestraps.

In yet another variation, as shown in FIG. 6, a protruding portion 324can be attached to the second end of the strap for selective engagementwith an excess strap retention slot 340 formed in the dorsal 302 orposterior 304 shells. Once the length of the strap has been adjusted,the excess strap length at the second end of the strap can be preventedfrom excessive movement or flapping by engaging the protruding portion324 attached to the second end of the strap with the excess strapretention slot 340. Thus, inadvertent loosening of the strap can beprevented.

As briefly mentioned above, a further variation of a circumferentialwalker 400 utilizing a multi-loop strap adjuster 442 in place of hookand loop portions on the strap 420 is shown in FIGS. 7 and 8.

The walker 400 is constructed in the manner discussed above with adorsal shell 402, a posterior shell 404, side shell portions 410, and anoutsole portion 412.

In a variation from the embodiment discussed above, each of the straps420 are anchored at a first end to the walker 400 along the posteriorshell 404 via connecting elements 436, which can be permanently fixedto, or integrally molded with the posterior shell 404. Of course, thestraps may alternatively be removably attached in a manner discussedabove or below.

As shown in FIGS. 7 and 8, the second ends 446 of the straps 420 arelooped through a receiving loop 430 of a buckle assembly 422, woundaround the segments 444 of the multi-loop strap adjuster 442, andsecured to the strap 420 itself via threading, ultrasonic welding, orany other suitable permanent or non-permanent attachment method.

In use, a protruding portion 424 of the buckle assembly 422 is removablysecured to an eyelet and seat formed in the posterior shell 404, asshown in FIGS. 1-4 and discussed in detail above. Of course, the buckleassembly 422 can be removably attached to the posterior shell 404 in anysuitable manner previously discussed. Once the buckle assembly issecured to the posterior shell 404, the multi-loop strap adjuster 442can be manipulated via sliding along the main portion of the strap 420to adjust the overall strap length, similarly to the methods previouslydiscussed.

Thus, as discussed above in detail, the length of the straps 420 needonly be adjusted once, and subsequent engagement and disengagement ofthe straps 420 to tighten the walker 400 around the lower leg, ankle,and foot are accomplished via the quick connect structure of the buckleassemblies 422, which are removably connected to the posterior shell404. This configuration provides quicker and easier donning and doffingof the walker 400 for all users and in particular for infirm or elderlypersons.

Additionally, the straps can be set once by a clinician in a controlledsetting to a specified tightness such that the patient does not need tofurther adjust the straps outside of the presence of the clinician. Inorder to prevent the unauthorized adjustment of the straps outside ofthe presence of the clinician, a removable and reusable clamp that canonly be removed by the clinician can be utilized to engage the strapssuch that the patient cannot further adjust the length thereof. Thestraps can also include indicia to track certain settings by way of thelength of the strap.

If further adjustment of the strap lengths is necessary in order toaccommodate, for example, a decrease in swelling of the lower leg,ankle, and foot, a patient can revisit the clinician for professionaladjustment of the strap lengths.

In further variations, the straps can be threaded through slots in thedorsal shell in order to prevent the dorsal shell from migrating alongthe dorsal aspect of the foot, ankle, and lower leg. Additionally, thestraps may be connected to or fed along the interior surfaces of theposterior shell in order to provide a further low profile brace, witheven less chance that the straps may inadvertently catch on externalobjects and become damaged or loosened.

A further variation of the embodiment of FIGS. 1-4 is shown in FIGS.9-13 utilizing an alternative quick connecting strap configuration. Aspreviously discussed, a circumferential walker 500 includes a dorsalshell (not shown in order to illustrate other features, see dorsalshells in FIGS. 1-4 and 7), a posterior shell 504, side shell portions510, and an outsole 512. The side shell portions 510 can wrap around theanterior portion of the walker 500 to form a toe protector portion.

Similarly to the above discussed embodiments, a number of quick connectstrap assemblies are attached to the walker to provide quick and easytightening of the straps for providing the desired amount of support tothe lower leg, ankle, and foot. The quick connect strap assemblies alsomake donning and doffing the walker easier for all users, in particularinfirm or elderly users.

As shown in FIGS. 9 and 13, each strap 520 includes a first end having aratchet or toothed portion 534, and a second end that carries a buckleassembly 522. The toothed portion 534 carries teeth that are oriented ina first direction for corresponding engagement with complementaryratchet or toothed portion 546 in a connecting assembly 536, whichcarries teeth that are oriented in a second, opposed direction to theteeth on the first end of the strap 520.

The connector assembly 536 is shown in FIGS. 9 and 12 and includes theaforementioned toothed portion 546, a connecting element 538 (generallyin the form of a plate element) pivotally attached to the connectorassembly 536 at pivot point 540, and a gap or slot 544 for receiving theexcess strap at the first end of the strap 520.

The first, toothed end 534 of the strap 520 is inserted under theconnecting element 538 via the gap or slot 544. The connecting element538 acts as a lever that pivots about the pivot point 540 and includesan actuation surface or actuation point 542, which can be actuated viathe application of pressure to rotate the connecting element 538 aboutthe pivot point 540 in order to increase the size of the gap or slot544. This actuation of the connecting element 538 can aid with insertingthe first toothed end 534 of the strap 520 into the gap or slot 544, orto release the engagement of the toothed portion 534 of the strap 520with the complementary shaped toothed portion 546 of the connectingassembly 536.

The connecting assembly 536 can be integrally formed with the posterior504 and side 510 shell portions, or it can be separately formed andattached to the posterior 504 and side 510 shell portions in anysuitable manner, such as ultrasonic welding or the use of adhesives.

Referring again to FIGS. 9 and 13, the second end of the strap 520carries a buckle assembly 522 that includes a pivoting portion 530 thatpivots about the end of the strap 520 at pivot point 532. The pivotingportion also includes a first locking protruding portion 524 and asecond nose protruding portion 526, each carried along one surfacethereof.

The buckle assembly 522 is configured to selectively engage a lockingelement 514, which is shown in FIGS. 9-11. The locking element 514 canbe integrally formed with the posterior 504 and side 510 shell portions,or it can be separately formed and attached to the posterior 504 andside 510 shell portions in any suitable manner, such as ultrasonicwelding or the use of adhesives.

The locking element 514 includes nose 516 and locking 518 hooks thatprovide selective engagement for the corresponding and complementaryshaped first locking protruding portion 524 and a second nose protrudingportion 526 carried on the buckle assembly 522.

In use, the user places the lower leg into the interior space of thewalker 500 defined between the dorsal and posterior 504 shells. Then,the first toothed ends 534 of the straps 520 are inserted a shortdistance into the gap or slot 544 of the connecting assemblies 536 toengage the straps 520 therewith. Next, the first locking protrudingportion 524 and the second nose protruding portion 526 carried on thebuckle assemblies 522 are inserted and engaged with the nose 516 andlocking 518 hooks of the locking elements 514 such that the pivotingportions 530 are engaged with the locking elements 514 in a flushmanner. Lastly, the first toothed ends 534 of the straps 520 are furtherinserted into the gap or slot 544 of the connecting assemblies 536 inorder to provide the appropriate amount of tightening in order toprovide the desired amount of support and stabilization to the lowerleg, ankle, and foot.

Of course, variations of these steps are contemplated. For example, thefirst toothed ends 534 of the straps 520 can be further inserted intothe gap or slot 544 of the connecting assemblies 536 prior to engagingthe pivoting portions 530 with the locking elements 514. If such a stepcauses the straps 520 to be too tight, the straps 520 may besubsequently loosened a desired amount by actuating the connectingelement 538 to release the straps 520 in order to achieve the desiredamount of tightening and support.

As previously discussed, the strap lengths can thus be adjusted once,and subsequent donning and doffing of the walker 500 does not requirereadjustment of the strap lengths, but merely engagement of the pivotingportions 530 with the locking elements 514 to provide a quick connectingstrap assembly.

As can be seen from the illustrations and the above discussion, thedorsal and posterior shell configurations utilizing the quick connectstrap configurations provide low profile walkers that ease donning anddoffing of the walkers, and also eases tightening of the straps foradjustment.

Additional features, such as inflatable liners with integrally attachedpumps, which can provide compression therapy and/or aid with properlyfitting the walker to the lower leg, a foam midsole to control heelstrike and roll over, and or a fabric exterior covering for the shellportions or a sleep cover accessory to aid with preventing undesiredcontact with the hard surfaces of the walker may also be provided.Further, the midsole can be formed with different materials orgeometries to control heel strike, toe off, and energy return. Anintegrated adjustable heel platform or wedge can also be provided.

Additionally, the shell portions may be formed from appropriatelyresilient materials or have particular resilient portions that allow theshell portions to better conform to the geometry of the user's lowerleg. In such a case, the rigidity and stabilization for the support areprovided via the tightening of the quick connect strap configurationsabout the resilient portions.

C. Detailed Description of a Hinged Circumferential Walker

As shown in FIGS. 14-24, the hinged circumferential, clam-shell likewalker 1100 is configured in an essentially two-piece construction toprovide a sleek and low profile device for use in stabilizing andsupporting the lower leg. Numerous advantages are obtained from such aconfiguration, such as lower weight, and less opportunity for the deviceto catch on external objects or clothing. Any weight savings will be asubstantial benefit, as a user must swing the mass of the walker, alongwith the leg, through the gait cycle.

The walker 1100 includes a semi-rigid, or substantially rigid shellconfiguration as previously described. The walker 1100 includes aposterior shell 1118 that extends from a posterior side of the lower legand ankle, along the distal surface of the foot, and terminates in aplantar shell portion 1120 that extends along the plantar surface of thefoot. The posterior shell 1118 includes lateral and medial (first andsecond) wing portions 1134 that extend partially around the lower leg,ankle, and foot from the posterior shell 1118 to wrap around the leg inorder to at least partially enclose and support the lower leg.

A dorsal shell 1102 is correspondingly shaped to the posterior shell1118 to at least partially surround or enclose the lower leg, ankle, andfoot to provide protection, support, and stabilization thereto. Thewalker 1100 can thus be formed in a clamshell-like configuration tofully encase and protect the lower leg, ankle, and foot. The dorsalshell 1102 is formed either in a single piece or in multiple shellportions. In the exemplary embodiment, the dorsal shell 1102 includes aproximal shell portion 1104 that is connected to a distal shell portion1106 via a flexible or resilient portion or hinge connection 1108.

The connecting portion 1108 may be a flexible or resilient materialpositioned between the proximal and distal shell portions 1104, 1106along the dorsal surface of the ankle and/or foot of a user in order toprovide a comfort fit between the walker and the ridge of the foot andankle. This connecting portion may be formed via overmolding a differentmaterial onto the end portions of the proximal and distal shell portions1104, 1106 to form a flexible or resilient expansion portion ormechanism. For example, the connecting portion can be formed via aflexible plastic or elastomer, such as, for example, ethylene vinylacetate (EVA). Of course, any suitable flexible material may beutilized, including silicone or natural or synthetic rubbers.Alternative hinge mechanisms, such as pivot pins and sleeves, or pianoor butterfly hinges, can also be used.

Overmolds and overmolding techniques are described in detail in U.S.Pat. Nos. 5,951,504, granted Sep. 14, 1999, 7,018,351, granted Mar. 28,2006, 7,288,076, granted Oct. 30, 2007, and 7,311,686, granted Dec. 25,2007, all commonly owned and incorporated herein in the entirety byreference.

The connecting portion 1108 will reduce or eliminate the formation of apressure point along the dorsal surface of a user's lower leg, ankle, orfoot. Further, due to the flexible nature or resiliency of theconnecting portion, when the dorsal shell 1102 is closed around theuser's lower leg, ankle, or foot, different sized anatomies can beaccommodated using the same sized walker 1100. Additionally, the walker1100 will automatically expand or contract due to swelling or reductionof swelling of the lower leg, ankle, and foot of a user.

As seen best in FIGS. 15 and 16, the proximal portion of the distalshell 1106 extends proximally to create a narrow portion of theconnecting portion 1108. In this manner, the distal shell 1106 providesa secure point for a strap (discussed below) to extend over fortransferring the closing force of the strap through the distal dorsalshell portion 1106.

As best seen in FIGS. 14, 16, 18, 21, and 22, the proximal portion 1104of the dorsal shell 1102 includes a flexible or resilient edge 1110along the terminal portion thereof. The edge 1110 can be formed viaovermolding as discussed above. The edge 1110 can therefore act as anexpansion mechanism to flex to accommodate different sized lower legs ofdifferent users. The edge 1110 also reduces or eliminates pressurepoints along the edge of the dorsal shell 1102. Therefore, a comfortablefit is achieved for numerous users having different sized anatomies.

As shown in FIGS. 14, 15, and 16, the distal portion 1106 of the dorsalshell includes a toe cover or protector portion 1112 that is configuredto enclose the foot and toes of a wearer and provide protection thereto.The anterior portion of the toe cover 1112 also includes receivingopenings or slots 1114 formed therein to cooperate with one or moreprojections 1128 formed along an extending toe portion 1126 of anoutsole 1124 to form an adjustable hinge point 1130 between the dorsaland posterior shells 1102, 1118. While the projections 1128 and openings1114 are shown to be elongated, any suitable shape can be utilized.Additionally, while a single projection 1128 and opening 1114 is shownat any particular plane, it will be recognized that a plurality ofprojections 1128 and openings 1114 can be provided at each plane.

The outsole 1124 can be integrally formed or attached along the plantarshell portion 1122 of the posterior shell 1118, for example, viaovermolding as discussed above. The outsole can be formed from anysuitable material, for example, a shock absorbing or resilient material.

As best seen in FIGS. 17 and 19, two projections 1128 are formed alongthe extending toe portion 1126. It will be recognized that fewer or moreprojections can be used to form the adjustable hinge point 1130. Theprojections 1128 are formed with an enlarged portion and a reduced sizeportion to have a snap configuration to be selectively engaged anddisengaged from the receiving openings 1114.

As best seen in FIGS. 16, 18, and 19, four receiving openings 1114 areformed in the anterior portion of the toe cover 1112 to selectivelyreceive the two projections 1128 therein in a snap configuration. Withthe configuration of four receiving openings 1114 and two snapprojections 1128, a user can selectively reposition the projections 1128in at least three distinct configurations with the openings 1114 toadjust the height of the dorsal shell 1102 with respect to the plantarshell portion 1122 (a fourth configuration can be formed by insertingthe uppermost projection into the lower most opening). Thus, the walker1100 can be adjusted to accommodate swelling of the lower leg, foot, andankle, or to accommodate different sized users. As discussed above,different numbers of projections and receiving openings can be utilizedto further adapt the walker 1100 to different anatomies.

As will be recognized, the positions of the projections 1128 andopenings 1114 can be altered, such that the projections extend from thetoe cover 1112 and the openings are formed in the extending toe portion1126. In an alternative variation, openings and projections can bepositioned both on the toe cover 1112 and the extending toe portion 1126in a suitable corresponding manner. Other various configurations ofhinges 1130 are discussed in detail below.

As shown in FIGS. 18, 19, and 20, when the projections 1128 are engagedwith the receiving openings 1114, a hinge 1130 is formed to allow thedorsal shell 1102 to be swung away from the posterior shell 1118 in aclamshell-like manner. Due to the use of two projections 1128, and theresiliency of the extending toe portion 1126, the dorsal shell 1102 isbiased towards the closed position shown in FIG. 18, such that thewalker 1100 will tend to automatically return to a closed configurationfrom the open configuration shown in FIG. 20. This will aid with donningthe walker 1100, especially for infirm users.

It can be seen that a user can pull open the dorsal shell 1102 away fromthe posterior shell 1118, via the hinge 1130, to allow insertion of thelower leg, ankle, and foot into the walker 1100. Once the user hasinserted their lower leg into the walker 1100, they can remove theopening force from the dorsal shell 1102, which will then tend to returnto the closed configuration to enclose the lower leg within the walker1100. The user can then utilize a connecting mechanism discussed belowto apply pressure and support and to maintain the walker 1100 in theclosed configuration.

It can be seen in FIGS. 14-24 that each of the dorsal and posteriorshells 1102, 1118 include clearance holes 1132 defined therein. Theclearance holes 1132 can be arranged in any suitable pattern. Forexample, some of the clearance holes 1132 may be arranged in asubstantially horizontal orientation and some of the clearance holes1132 may be arranged to be oriented substantially in the proximal-distaldirection. The clearance holes may be oriented in the same or differentdirections or at the same angle or different angles. The clearance holes1132 can also reduce the weight of the walker 1100. Further, theclearance holes 1132 can act as vents to allow heat and perspiration topass from inside the walker 1100 to the exterior thereof. Additionally,the clearance holes 1132 may also allow the dorsal and posterior shells1102, 1118 to have some resiliency to accommodate swelling of a limb orusers having different sizes of lower legs, ankles, and feet.

As best shown in FIGS. 14, 16, 23, and 24, additional expansionmechanisms are formed in the posterior shell 1118 to reduce or eliminatepressure points and to accommodate users having different sizes of lowerlegs, ankles, and feet. In particular, a flexible or resilient edge andexpansion joint 1136 is formed along the edges of and between theposterior of the wing portions 1134. The expansion joint 1136 can beformed having a larger dimension at the proximal end and tapering downto a smaller dimension at the distal end. The expansion joint 1136 canbe overmolded as discussed above. As shown, the expansion joint 1136includes a number (any desired) of expansion holes 1138 passingtherethrough that can be arranged in any suitable manner. The holes 1138can have any desired shape or size and can also act as vents.

Due to the resiliency or flexibility thereof, the expansion joint canexpand to accommodate swelling or different sized anatomies, and canreduce or eliminate pressure points. Additionally, since the expansionjoint 1136 extends along the posterior of the posterior shell 1118between the wing portions 1134, the flexibility or resiliency of theexpansion joint, aided by the expansion holes 1138, allows the proximalor upper portions of the wing portions to expand away from each other toaccommodate swelling of the limb or users having different sized calves,without losing rigidity in the sagittal plane (the plane dividing thewalker 1100 into medial and lateral sides). Due to the larger proximalend, the expansion joint allows more expansion between the proximalportions of the wing portions 1134 than at distally spaced positions ofthe wing portions 1134. The expansion joint and edges 1136 also reduceor eliminate pressure points.

As shown in FIG. 24, the thickness of the proximal, anterior portions ofthe wing portions 1134 can also be reduced with respect to the thicknessof the rest of the posterior shell 1118 such that the wing portions 1134may more easily expand to accommodate larger sized calves and lowerlegs.

Thus, in view of the above description, a walker 1100 has adjustabilityand expansion capabilities to accommodate users having different sizedanatomies or swelling of the limb, and further to reduce or eliminatepressure points to provide a circumferential walker that has acomfortable fit for many different users.

The walker 1100 is also easy to use due to the quick connectingmechanisms, described in detail below, that allow quick and easyengaging and disengaging of straps to don and doff the walker 1100. Thewing portions 1134 of the posterior shell 1118 include two pairs ofeyelets 1140 that include seats 1142. The eyelets 1140 and seats 1142selectively engage projections on strap retaining assemblies 1144 orbuckle assemblies 1148. In this configuration, with the toe hinge 1130and a sufficiently rigid distal shell portion 1106, it is only necessaryto use two straps to close and secure the walker 1100. Thus, the form ofthe walker are more low profile to provide a cleaner appearance and toreduce possible contact with foreign objects, and donning and doffing ofthe walker is made easier since wearers no longer need to stretch andreach all the way to the anterior portion of the walker to apply a “toe”strap. Of course, a third “toe” strap, or any desired number of strapscan be provided to add additional compression and support.

Each of the strap retaining assemblies 1144 or buckle assemblies 1148respectively include a receiving loop or D-ring 1146, 1150 to receive alooped portion of a strap 1152 therethrough. The straps may beconventional hook and loop fastening straps to provide adjustability. Asdiscussed in detail below, the strap length need only be adjusted aninitial time (or infrequently to accommodate swelling or reduction ofswelling of tissues), and each subsequent donning and doffing of thewalker 1100 can be achieved utilizing the quick connectingconfiguration.

As seen in FIGS. 15, 18, 21, and 22, a pump assembly 1154 and a valveassembly 1156 are integrated with the dorsal shell 1102. The pumpassembly 1154 and valve assembly 1156 are connected to bladdersdiscussed in detail below that are retained within the walker 1100 toprovide additional compression and support to the lower limb of theuser.

The pump assembly 1154 can have any suitable configuration and mayinclude a resilient or flexible diaphragm having an inlet (which may bea one-way inlet) and a one-way outlet to transfer air from the exteriorof the pump to the bladders. Any available manual or electric pump mayalso be utilized or integrated into the walker 1100. The valve assembly1156 may be a pressure release valve having single or selectable flowpaths. Any available release valve and/or selector valve may be used,for example a push button release valve.

As shown in FIGS. 15 and 23, the walker 1100 may have structuresdesigned to selectively strengthen the dorsal or posterior shells 1102,1118 in a specific direction. In particular, the dorsal shell 1102 caninclude a reinforcing ridge 1116 that extends generally longitudinallyalong both lateral and medial sides thereof. Additionally, the posteriorshell 1118 can include a reinforcing ridge 1120 positioned to theposterior of the eyelets 1140 and oriented generally in theproximal-distal direction thereof.

In addition to adding structural support, the reinforcing ridges 1116and 1120 can also enhance the low profile form of the walker. Thereinforcing ridges 1116 can further provide additional support forengaging the straps 1152 to provide sufficient support and stabilizationto the lower leg of the user.

Variations and further explanations of components for a hingedcircumferential walker are provided below.

D. Variation of a Posterior Shell for use With a Hinged CircumferentialWalker

A variation of a posterior shell 1160 for use with a hingedcircumferential walker is shown in FIGS. 25 and 26. The posterior shell1160 has generally the same configuration as previously described,including a plantar shell portion 1162.

An indentation or groove 1164 is provided along the medial-lateral axisof a proximal surface 1166 of the plantar shell portion 1162. Theindentation or groove 1164 can extend along the entire length of theplantar shell portion 1162 or over only a portion thereof. Theindentation may act as a guide for an inflation tube for bladders, aswill be discussed in detail below, such that the inflation tube will notbe compressed to cause blockage thereof.

The posterior shell 1160 also includes wings 1174, as described above.Eyelets 1176 and seats 1178 are provided in the shell wings 1174 toselectively anchor and retain buckle assemblies and strap retainingassemblies. In this variation, three sets of eyelets 1176 and seats 1178are positioned in the shell wings 1174 so that three straps can be usedto tighten and close the walker. It will be recognized that any desirednumber of sets of eyelets can be provided to accommodate any desirednumber of straps.

The posterior shell 1160 and wings 1174 also include clearance holes1172 to add to the low profile form, to reduce weight, to provideventing of heat and perspiration, and to provide some resiliency to theposterior shell 1160 and wings 1174 in the same manner as discussedabove. The clearance holes 1172 may be arranged in any suitableconfiguration, as previously discussed.

As shown in FIG. 25, each seat 1178 has associated therewith a bucklerotation restriction groove 1180. As will be discussed in detail below,the buckle rotation restriction groove 1180 cooperatively engages with aprotrusion on the buckle assembly or strap retaining assembly to limitthe amount that the straps can move. Thus, the straps are maintained inposition on the walker to provide the appropriate amount ofstabilization and support to the user's lower leg.

As also shown in FIG. 25, the posterior shell 1160 also includesreinforcing ridges 1182 positioned in the posterior of the shell andextending in the proximal-distal direction. The reinforcing ridges 1182function in the same manner as previously discussed.

As also previously discussed, an expansion joint and resilient orflexible edge 1184 is positioned between the posterior of the wingportions 1174 and extending in the proximal-distal direction. In thisvariation, the expansion joint 184 includes expansion openings 1186 thatare horizontally oriented and which provide the same function as theexpansion holes 1138 discussed above. The expansion openings 1186 candecrease in length from the proximal end to the distal end of theexpansion joint 1184 corresponding to the tapered shape of the expansionjoint 184.

As shown in FIG. 26, the plantar shell portion 1162 also includes adistal surface 1168. Protruding ribbing 1170 may be formed on the distalsurface 1168 in a length-wise and/or cross-wise manner to create wells,and thus to provide additional support and reinforcement to the toe-offarea of the walker. Such ribbing 1170 can be provided to the plantarshell portion of any posterior shell disclosed herein to provideadditional support and reinforcement to the toe-off area of the walker.The protruding ribbing can extend over the entire length of the distalsurface 1168, or over any desired portion thereof.

Next, variations of bladders for use with hinged circumferential walkersto apply compression therapy to a limb are discussed.

E. Various Bladder Configurations for use With a Hinged CircumferentialWalker

As shown in FIGS. 27-29 a bladder configuration for use with hingedcircumferential walkers is illustrated. The walker is constructed in anysuitable manner as discussed herein and includes a posterior shell 1190having a plantar shell portion 1192, and a correspondingly shaped dorsalshell 1194. The bladders can be inflated or deflated via associatedinflation ports or integrally carried pumps. The inflation port or pumpmay be integrally carried in a clearance hole of the walker shells. Asingle pump can be provided to inflate one or more bladderssimultaneously or individually to different pressures, or each bladdermay be provided with an associated pump. The pumps are attached orcarried by the walker so that they are not easily misplaced. Further,the pumps or inflation ports can be configured to be usable with a fluidor liquid to provide hot and/or cold therapy.

The inflatable bladders can also be configured to be ventilated byhaving slits passing through welded portions of the bladders. The weldedportions can be used to create chambers within the bladders, and the useof more welded portions provides more chambers, as well as more slits toenable greater ventilation.

As shown in FIGS. 27-29, a configuration of medial, lateral, and dorsalbladders 1196, 1198 are shown. The medial and lateral bladders 1196 aregenerally shaped to correspond to the medial and lateral side portionsof the posterior shell 1190. The dorsal bladder 1198 is generally shapedto correspond to the dorsal shell 1194. The medial and lateral bladders1196 each include a bulged portion 1206 that is arranged to be locatedin the posterior portion of the walker. The bulged portions 1206 fill inthe space around the Achilles tendon so that the lower leg will fitsnugly within the walker, and so that the ankle is securely locked inposition. The bladder shapes are further optimized to focus compressionwhere it is needed and uniform compression is provided to all areas ofthe anatomy where the bladders provide compression.

The medial, lateral, and dorsal bladders 1196, 1198 are connected via aconnecting portion 1200 that extends from one end of the dorsal bladder1198 to a central portion of the medial and lateral bladders 1196. Theconnecting portion 1200 extends from the dorsal bladder 1198 at thedorsal shell hinge portion and along the plantar shell portion 1192under the arch and plantar surface of the foot (an indentation or grooveof the type shown in FIG. 25 can be used to prevent blocking of theconnecting portion 1200). Thus, all of the bladders 1196, 1198 can besimultaneously inflated via the inflation tubing 204 connected to anopposed end of the dorsal bladder 1198. The inflation tubing isconnected to a pump, such as described above.

The bladders 1196, 1198 can be formed of two sheets of air imperviousplastic material that is welded around the edges to create air chamberstherebetween. Perspiration wicking material can be applied to thesurfaces of the bladders 1196, 1198 that are configured to contact thewearer's anatomy. The bladders 1196, 1198 can be secured to the interiorof the walker in any suitable manner, such as, for example, viaadhesive, hook and loop fasteners, or snap fasteners.

In addition to the welds forming the bladders, welds and/or holes 1202are arranged in the bladders 1196, 1198 to serve a number of functions.The welds 1202 in the bladders 1196, 1198 can serve to direct airflowwithin the bladders and also to provide heat and perspiration wickingchannels along the surfaces of the bladders 1196, 1198.

In addition to the bladders 1196, 1198, foam or other types of padding1208 can be provided to reduce pressure points along the interior of thewalker. The padding 1208 can be any suitable padding and can be securedto the interior of the walker in any suitable manner, such as viaadhesive, hook and loop fasteners, or snap fasteners.

A further variation of a bladder configuration for use with a hingedcircumferential walker is shown in FIG. 30. Medial and lateral bladders1210 are connected to a dorsal bladder 1212 via a connecting portion ortubing 1214. The medial and lateral bladders 1210 and the dorsal bladder1212 are shaped in a similar manner as discussed above. The medial andlateral bladders 1210 include the bulged portions 1220 as discussedabove to surround and support the area around the Achilles tendon.Additionally, the dorsal bladder includes an inflation tube 1218connected at one end thereof.

The dorsal bladder 1198 includes longitudinally extending openings 1222that provide venting for heat and perspiration. The welds that formopenings 1222 also form air flow channels and chambers within the dorsalbladder 1198 to guide airflow from the dorsal bladder 1198 to theconnecting portion 1214.

The connecting portion 1214 extends along a proximal surface of aplantar shell portion under the arch and plantar surface of the foot andconnects to one end of either the medial or lateral bladder 1196. Inthis manner, the bladders 1196, 1198 can be simultaneously inflated ordeflated via the use of a pump assembly and valve assembly as previouslydiscussed.

The medial and lateral bladders 1196 also include a central weldedportion 1216 that extends along the bladders 1196 to provide a heat andperspiration dissipation channel. The welded portion 1216 extends to aposition near an opening or vent 1222 in the bladders 1196 so that heatand perspiration can rise along the welded portion 1216 to be ventedfrom the openings 1222. The openings 1222 in the bladders 1196 areappropriately shaped to provide breathability to the bladders 1196without degradation of compression being applied to the lower limb.

A further variation of a bladder assembly for use with a hingedcircumferential walker 1230 is shown in FIGS. 31 and 32. The walker 1230includes a dorsal shell 1232 and a posterior shell 1234. A pump assembly1236 is integrated into the proximal portion of the dorsal shell 1232and is connected to a selector/release valve assembly 1238, which isalso integrated into the dorsal shell 1232.

The selector/release valve assembly 1238 is connected to medial andlateral bladders 1242, and a dorsal bladder 1244 via independentinflation tubing 1240. Thus, the selector/release valve assembly 1238can be used to selectively inflate or deflate different bladders toprovide more or less compression to different portions of the anatomy.The inflation tubing 1240 for the medial and lateral bladders 1242extends along medial and lateral sides of the posterior shell 1234 toone end of the medial and lateral bladders 1242.

As shown in FIG. 32, the dorsal 1244 and medial and lateral bladders1242 have a similar shape as previously discussed. The medial andlateral bladders 1242 include the bulged portions 1248 to surround andsupport the Achilles tendon area of the lower leg, as discussed above.

Additionally, each of the bladders 1242, 1244 include weld portions oropenings 1246 to act as airflow guides and heat and perspirationdissipation channels or venting openings as previously discussed.

Although medial and lateral bladders 1242 and a dorsal bladder 1244 areillustrated, some of these bladders may be removed, or additionalbladders may be added in order to concentrate compression onto specificareas of the anatomy. For example, an additional planter bladder can bepositioned under the arch and/or plantar surface of the foot in order toprovide arch support.

Next, a buckle assembly for use with circumferential walkers isdescribed.

F. Buckle Assembly for Use with a Hinged Circumferential Walker

The buckle assembly 1250 shown in FIGS. 33-36 has the same configurationas the buckle assembly 1148 mentioned above.

As shown in FIG. 34, the buckle assembly 1250 includes a main portion1252 connected via a first hinge 1264 to a clamping portion 1266. Theclamping portion 1266 is connected via a second hinge 1272 to a strapretaining portion 1274.

The main portion 1252 includes ergonomically shaped finger indents orgrips 1254 that enhance the wearer's ability to grip and attach the mainportion 1252 to the shell of the walker.

As shown in FIG. 35, the main portion 1252 also includes a protrudingportion 1256 extending from a surface thereof. The protruding portion1256 includes a head portion 1258 and a reduced size portion 1260. Thehead portion 1258 and a reduced size portion 1260 are configured toengage the eyelet 1280 and seat 1282 in the posterior shell wing 1278(FIG. 36) in a recognized manner. Thus, the buckle assembly can beselectively attached and detached from the posterior shell wing 1278.

As further shown in FIG. 36, a reduced dimension or locking portion 1286is formed between the eyelet 1280 and the seat 1282. The reduced sizeportion 1260 of the protruding portion is sized to be slightly largerthan the locking portion 1286, such that when the reduced size portion1260 is seated within the seat 1282, the locking portion 1286 provides asnap engagement thereof to prevent inadvertent removal of the reducedsize portion 1260 and the buckle assembly 1250 from the seat 1282.

As further shown in FIG. 35, the main portion 1252 further includes abuckle rotation restriction projection 1262 extending therefrom. Theprojection 1262 is configured to engage the buckle rotation restrictiongroove 1284 in the posterior shell wing 1278 (FIG. 36) in the mannerpreviously discussed to prevent rotational movement of the straps. Inthis manner, a user can easily manipulate the straps and buckleassemblies 1250, which stay in position while a user attemptsmanipulation.

Returning to FIG. 34, the clamping portion 1266 includes an actuationportion or tab 1268 that can be manipulated by a user to clamp andunclamp the clamping portion 1266 via selective rotation about the firsthinge 1264.

As further shown in FIGS. 34 and 35, an engaging portion or snap lockingprojection 1270 is formed on the clamping portion 1266 to selectivelyengage the main portion 1252. In this manner, the clamping portion 1266can be clamped and unclamped from the main portion 1252 to provide quicktightening and loosening of straps once the straps have been initiallytightened.

The strap retaining portion 1274 includes a receiving loop or D-ring1276 to receive a looped end of a strap therethrough. Clamping orunclamping of the clamping portion 1266 is transmitted through the strapretaining portion 1274 via relative rotation at the second hinge 1272.Thus, Clamping or unclamping of the clamping portion 1266 is alsotransmitted to the strap connected to the strap retaining portion 1274.

As discussed above, the straps need only to be tightened once initially(or infrequently to accommodate swelling or reduction of swelling oftissues) and the buckle assemblies 1250 can be utilized to provide quickconnecting and tightening or loosening of the straps. When a user beginsthe donning process, the straps are initially loosened and the buckleassemblies 1250 are removed from the walker to allow the dorsal shell ofthe walker to be rotated away from the posterior shell. Thus, an openingbetween the dorsal and posterior shells allows a wearer to positiontheir lower limb within the walker. As discussed above, the dorsal shellwill tend to close when the opening force is removed.

Once the dorsal shell has closed over the posterior shell, the buckleassemblies 1250 are attached to the eyelets and seated in the posteriorshell in the unclamped configuration. The clamping portions 1266 arethen clamped and the straps are initially tightened to provide theappropriate amount of support and stabilization to the lower leg.

When the user begins the doffing process, the clamping portions 1266 areunclamped, and the buckle assemblies 1250 are removed from the seats andeyelets of the posterior shell. Then, the user can pivot the dorsalshell away from the posterior shell to remove the lower leg from thewalker.

To repeat the donning process, the user need only insert the lower legwithin the walker, attach the buckle assemblies 1250 to the posteriorshell, and clamp the clamping portions 1266. Thus, there is no need toadjust the strap tension each time the user dons the walker.Accordingly, a more convenient and easy to use configuration is providedto assist users that may have trouble manipulating numerous straps everytime they need to don and doff the walker.

The configurations of the protruding portion 1256, head portion 1258,reduced size portion 1260, strap retaining portion 1274, and bucklerotation restriction projection 1262 of the buckle assembly 1250 canalso be utilized in the strap retaining assembly 1144 discussed above toselectively connect the strap retaining assembly 1144 to the posteriorshell wing 1278. In this manner, the buckle assemblies 1250 and thestrap retaining assemblies 1144 are interchangeable from one side of thewalker to the other. Accordingly, the straps and buckle assemblies 1250can be easily oriented for manipulation by right or left handed users.Additionally, the straps can be completely removed from the walker forany desired reason, such as replacement of components, or for storage.

Further variations of components for use with a hinged circumferentialwalker are discussed next

G. Variations of Components for use With a Hinged Circumferential Walker

A variation of an expansion joint 1294 for use with a circumferentialwalker is shown in FIGS. 37 and 38.

A posterior shell 1290 generally constructed in accordance with theprinciples discussed above is shown in FIG. 38. The posterior shell 1290includes medial and lateral wing portions 1292 that define an openingtherebetween in the proximal section of the posterior portion of theposterior shell 1290. An expansion joint 1294 generally of the typedescribed above is situated in the opening between the wing portions1292. The wing portions 1292 include proximal edges that carry flexibleor resilient expansion joint edges 1296 to accommodate various sizedanatomies, or swelling, and/or to reduce or eliminate pressure points,in a manner previously discussed.

The expansion joint 1294 includes a proximal portion 1298, a distalportion 1300, and a reinforcing portion 1302 located in the proximalportion 1298. The expansion joint 1294 has a larger dimension in theproximal portion 1298 and tapers to a smaller dimension in the distalportion 1300, in a manner discussed above. The reinforcing portion 1302has a similarly configured tapering shape from the proximal portion tothe distal portion.

Similarly to the expansion joints discussed above, the expansion joint1294 also includes expansion holes or openings 1304 arrangedhorizontally, or with a slight angled orientation in the proximal-distaldirection. The expansion holes or openings 1304 extend in theproximal-distal direction between the edges of the expansion joint 1394and between the reinforcing portion 1302 and the edges of the expansionjoint 1394. The expansion holes or openings 1304 function as describedabove. Expansion struts 1306 are defined between the expansion openings1304.

As can be seen in FIG. 38, the expansion struts 1306 have a smallerthickness than the remaining portions of the expansion joint 1294, suchas the reinforcing portion 1302. In this manner, the expansion struts1306 can more easily expand (in a manner similar to a rubber band) toaccommodate various sized anatomies (for example, a larger calf size),or swelling, and/or to reduce or eliminate pressure points, in a mannerpreviously discussed.

A further variation of a dorsal shell 1310 for use with acircumferential walker is shown in FIGS. 39 and 40.

The dorsal shell 1310 generally constructed in accordance with theprinciples discussed above is shown FIG. 39. The dorsal shell 1310includes a proximal edge portion 1312 that is shaped to engage the shinof a wearer. In order to accommodate different sized anatomies and/or toreduce or eliminate pressure points, a living hinge 1314 is providedalong the proximal edge portion 1312 to allow the proximal edge portion1312 to flex or bend about the living hinge 1314.

As shown in FIG. 40, the living hinge 1314 is a thin section of materialbetween the proximal edge portion 1312 and the main section of thedorsal shell 1310. The living hinge 1314 has a thickness that is lessthan the thickness of the rest of the dorsal shell 1310 or the proximaledge portion 1312. Since the living hinge 1314 has a smaller thicknessthan the dorsal shell 1310 or the proximal edge portion 1312 theproximal edge portion 1312 is able to bend or flex with respect to thedorsal shell 1310 around the living hinge 1314.

The specific construction of the living hinge 1314 is dependent upon thedesired amount of flexing, and the direction of flexing. The actualthickness and shape of the living hinge 1314 is dependent upon thethickness of the dorsal shell 1310 and the proximal edge portion 1312.The living hinge 1314 may therefore be formed in any suitable shape,size and orientation, in order to provide the desired flexingcharacteristics.

For example, the living hinge 1314 may be provided by a recessed line orgroove along the anterior surface of the proximal portion of the dorsalshell 1310. The length of the living hinge 1314 may extend substantiallyalong the entire proximal edge portion 1312. Alternatively, the lengthof the living hinge 1314 may have any suitable length. The actualprocess of forming the living hinge 1314 will be understood by a skilledartisan.

The dorsal shell 1310 also includes a pump receiving opening 1316. Thepump receiving opening 1316 includes a tapered ridge 1318 extendingaround the periphery of the opening 1316.

As shown in FIG. 40, a flexible bulb type pump 1320 is inserted throughthe pump receiving opening 1316. The pump 1320 includes a flexible lip1322 extending around the periphery of the pump 1320 for cooperativeengagement with the tapered ridge 1318 to retain the pump 1320 with thepump receiving opening 1316 of the dorsal shell 1310.

The pump 1320 includes an inlet 1324 that allows air to flow into thebody of the pump 1320, but is selectively closed when the pump isactuated so that air does not flow out of the pump 1320 through theinlet. The pump 1320 also includes an outlet 1326, opposed to the inlet1324, and retaining a one-way outlet valve 1326 therein, such thatactuation of the pump causes air to flow from the inlet 1324 through theone-way outlet valve 1326 towards the bladders (not shown but describedin detail above).

A push button release valve 1330 is incorporated with the pump 1320 torelease the pressure within the bladders. An actuation surface 1332 ofthe release valve 1330 is connected to a valve stem 1336 and is biasedtoward the unactuated position via a biasing element or spring 1334.

The valve stem 1336 passes through a valve seat 1340 and carries asealing element 1342 thereon for selective engagement with the valveseat 1340 to open and close the valve 1330. The valve stem 1336 isengaged with a guide post 1338 to guide the reciprocating action of thevalve stem 1336 within the valve 1330.

The valve 1330 passes through an opening 1344 in the dorsal shell 1310to be carried thereon. The opening 1344 includes an anti-rotation cutout1346 which engages an anti-rotation ridge or projection formed on thebody of the valve 1330 to prevent rotation of the valve 1330 within theopening 1344.

While a specific configuration of a pump 1320 and release valve 1330 isdescribed, it will be recognized that any suitable pump and valvearrangement may be utilized.

A further variation of a dorsal shell 1476 for use with acircumferential walker 1470 is shown in FIG. 41.

The walker 1470 shown in FIG. 41 includes a posterior shell 1472 havinglateral and medial side portions 1474 and a dorsal shell 1476. Thedorsal shell has proximal 1478 and distal 1482 portions connected toeach other via a flexible or hinge portion 1480. The distal shellportion 1482 is connected at an anterior portion thereof to an outsole1486 (or a planter shell portion) via a hinge 1488 of any type describedherein.

The distal dorsal shell portion 1482 also includes lateral and medialflap portions 1484 extending distally therefrom. The flap portions 1484provide mechanisms to align the dorsal shell 1476 with the posteriorshell 1472 during opening and closing of the walker 1470 about the hinge1488. The flap portions 1484 also aid to retain the distal dorsal shellportion 1482 with the plantar shell of the posterior shell 1472.

Next, variations of hinge configurations for use in a hingedcircumferential walker are discussed.

H. Variations of Hinge Configurations for Use with a HingedCircumferential Walker

Additional variations of hinge configurations for use with a hingedcircumferential walker are shown in FIGS. 42-50.

In a first variation, shown in FIG. 42, a dorsal shell 1350 includes atoe cover portion 1352 and an extension portion 1354 extendingtherefrom. A living hinge 1356, as described above, is formed betweenthe extension portion 1354 and the dorsal shell 1350 to allow theextension portion 1354 to flex or bend with respect to the dorsal shell1350. The extension portion 1354 also includes receiving openings 1358to selectively engage, in a manner previously discussed, flexibleprotrusions 1368 positioned on either a plantar shell portion 1362 of aposterior shell 1360 or in a cutout 1366 in an outsole 1364. If theflexible protrusions 1368 are positioned on the plantar shell portion1362, the cutout 1366 of the outsole 1364 can create a receiving spacefor the extension portion 1354 to be received therein to maintain a lowprofile device. Alternatively, the flexible protrusions 1368 can bepositioned and formed within the cutout 1366 of the outsole 1364 tocreate a receiving space for the extension portion 1354 to be receivedtherein to maintain a low profile device.

In the variation shown in FIG. 43, the location of the flexibleprotrusions 1368 and receiving openings 1358 is alternated from thatshown in FIG. 42, such that the flexible protrusions 1368 are formed onthe extension portion 1354 and the receiving openings 1358 are formed inthe cutout 1366.

In each case, the living hinge 1356 of the extension portion 1354 allowsthe dorsal shell 1350 to rotate with respect to the posterior shell 1360so that the circumferential walker can be opened to allow the wearer toplace their lower leg therein. As discussed above, the flexibleprotrusions 1368 and receiving openings 1358 can be provided in theplurality to allow the wearer to adjust the spacing between the dorsalshell 1350 and the posterior shell 1360 in order to accommodate swellingor different size anatomies. While four protrusions and receivingopenings are shown, it will be recognized that more or fewer protrusionsand receiving openings can be utilized.

A further variation of a hinge configuration is shown in FIG. 44. Aswith previous variations, the walker includes a dorsal shell 1370 with atoe cover portion 1372. Receiving openings 1374 are positioned in thedistal anterior portion of the toe cover portion 1372.

A posterior shell 1376 has a plantar shell portion 1378 with anextension portion 1380 extending from the anterior portion thereof andan outsole 1386 formed thereon. A living hinge 1382 is formed betweenthe extension portion 1380 and the plantar shell portion 1378 to allowthe extension portion 1380 to flex or bend about the plantar shellportion 1378. At least one flexible protrusion 1384 is formed on theextension portion 1380 to selectively engage at least one of thereceiving openings 1374. Of course, it will be recognized that theposition of the flexible protrusion 1384 and the receiving openings 1374can be alternated.

As with previous variations, the engagement between the flexibleprotrusion 1384 and the receiving openings 1374 can be used to adjustthe size of the walker. Additionally, the living hinge 1382 allows thedorsal shell 1370 to rotate about the planter shell portion 1378 toallow a user to easily don and doff the walker.

In a further variation shown in FIG. 45, the hinge can be formed byusing fasteners. In particular, the dorsal shell 1390 includes a toecover portion 1392 with a first connector portion 1394 formed at theanterior distal portion thereof.

The posterior shell 1396 includes an outsole 1398 formed thereon. Theoutsole 1398 includes an extension portion 1400 formed at the anteriorportion thereof and carries a second connector portion 1402.

As shown in FIG. 45, the first connector portion 1394 is located on anexterior surface of the dorsal shell 1390 and the second connectorportion 1402 is located on an interior surface of the extension 1400 ofthe outsole 1398. It will be recognized that these locations may bealternated.

The first and second connector portions 1394, 1402 are configured toallow selective and adjustable connection therebetween. Exemplaryconfigurations can include hook and loop fastening material, or aplurality of snap connections. It will be recognized that either thefirst or second connector portions 1394, 1402 can be formed from hookmaterial and the other formed from loop material, and vice versa. Thehook and loop material can be attached to the dorsal shell 1390 andextension 1400 of the outsole 1398 via adhesive or other suitablemechanism. Alternatively, the hook material and loop fabric can bedirectly injection molded with or into the respective dorsal shell 1390and extension 1400 of the outsole 1398. Exemplary methods of moldinghook material into a shell are described in detail in U.S. Pat. Nos.5,368,549, granted Nov. 29, 1994, 5,656,226, granted Aug. 12, 1997, andRE37,338, granted Aug. 21, 2001, each incorporated herein in theentirety by reference.

As will be understood, the first and second connector portions 1394,1402 can be disengaged and engaged to alter the distance between thedorsal shell 1390 and the posterior shell 1396 to accommodate swellingor different size anatomies. Further, when the first and secondconnector portions 1394, 1402 are engaged, the dorsal shell 1390 canrotate with respect to the posterior shell 1396 to allow a wearer toeasily don and doff the device.

A further variation of a hinge arrangement is shown in FIG. 46. In thisconfiguration a dorsal shell 1410 includes a first strap receiving slotor D-ring 1416 at an anterior distal portion thereof.

A posterior shell 1412 includes an outsole 1414 formed thereon that hasa second strap receiving slot or D-ring 1418 at an anterior portionthereof. A strap 1420 has one end looped over and secured to itself atthe first strap receiving slot 1416. The strap is subsequently threadedthrough the second strap receiving slot 1418 and threaded up along andthrough a strap guide 1422 on the proximal surface of the dorsal shell1410. The strap has a first connector portion 1424 at the end thereoffor selective engagement with a second connector portion 1426 on theproximal surface of the dorsal shell 1410.

The first and second connector portions 1424, 1426 can be formed asdiscussed above from hook and loop fasteners to allow selectiveengagement therebetween and adjustment of the spacing between the dorsalshell 1410 and the posterior shell 1412 to accommodate swelling ordifferent size anatomies. Further, due to the flexibility of the strap,the dorsal shell 1410 can rotate with respect to the posterior shell1412 to allow a wearer to easily don and doff the device.

Although not shown, the strap can be secured at a first end to theoutsole, threaded through the D-ring on the dorsal shell, and secured toa bottom surface of the outsole. A cutout on the outsole, similar to thecutout described above, can be provided to allow the strap to be securedtherein to provide a low profile sole.

A further variation of a hinge configuration is shown in FIGS. 47 and48. A dorsal shell 1430 includes a toe cover portion 1432 that has asreceiving opening 1434 formed at the anterior distal portion thereof.

A posterior shell 1436 includes a plantar shell portion 1438 and anoutsole 1446 formed thereon. An extension portion 1440 extends from theplantar shell portion 1438 at an anterior portion thereof. A livinghinge 1442 is formed between the extension portion 1440 and the plantarshell portion 1438 in a manner discussed above. Alternatively, theextension portion 1440 can be formed as a separate piece that isattached to the plantar shell portion 1438 in any suitable manner.

The extension portion 1440 includes a ratchet structure 1444 formed onone surface thereof. The extension portion 1440 is arranged to bereceived through the receiving opening 1434 to connect the dorsal shell1430 to the posterior shell 1436 so that the dorsal shell 1430 canrotate with respect to the posterior shell 1436 to allow a wearer toeasily don and doff the device.

When the dorsal shell 1430 is rotated to an open position with respectto the posterior shell 1436, the ratchet structure 1444 can easily slidewithin the receiving opening 1434 to adjust the spacing between thedorsal shell 1430 and the posterior shell 1436.

When the dorsal shell 1430 is rotated to a closed position, theextension portion 1440 flexes or bends about the living hinge 1442 andthe ratchet structure 1444 engages the edge of the receiving opening1434 to maintain the dorsal shell 1430 in engagement with the posteriorshell 1436.

In a similar configuration shown in FIGS. 49 and 50, the dorsal shell1450 includes a toe cover portion 1452 and an extension portion 1454extending from an anterior distal portion thereof. A living hinge 1456is formed between the toe cover portion 1452 and an extension portion1454 to allow the extension portion 1454 to flex or bend about the toecover portion 1452. A ratchet structure 1458 is formed on a surface ofthe extension portion 1454. It will be recognized that the extensionportion 1454 can be formed as a separate piece that is connected to thedorsal shell 1450 in any suitable manner.

A posterior shell 1460 has a plantar shell portion 1462 having anoutsole 1466 formed thereon. A receiving opening 1464 is formed at ananterior portion between the plantar shell portion 1462 and the outsole1466. The extension portion 1454 is configured to extend into thereceiving opening 1464, and functions in a manner previously discussedto allow adjustment of the spacing between the dorsal shell 1450 and theposterior shell 1460 to accommodate swelling and different sizeanatomies.

Another variation of a hinge for use with a hinged circumferentialwalker is shown in FIG. 51. The dorsal shell 1490 includes a toe coverportion 1492 that has receiving openings 1494 formed therein.

The posterior shell 1496 has an outsole 1498 formed thereon or attachedthereto. The outsole 1498 includes an extension portion 1500 extendingfrom an anterior portion thereof. Projections 1502 extend from theanterior surface of the extension portion 1500 for selective engagementwith the receiving openings 1494 of the dorsal shell 1490.

This configuration prevents accidental disengagement of the projections1502 from the receiving openings 1494 due to the forward migration ofthe wearer's foot within the walker during the gait cycle. Since theprojections 1502 are formed on the anterior surface of the extensionportion 1500, even if the wearer's foot migrates all the way to theanterior portion of the walker, the foot will not cause the projections1502 to accidentally disengage from the receiving openings 1494.

Another variation of a hinge for use with a hinged circumferentialwalker is shown in FIG. 52. The dorsal shell 1510 includes a toe coverportion 1512 that has receiving openings 1514 formed therein.

The posterior shell 1516 has an outsole (or plantar shell portion) 1518formed thereon or attached thereto. The outsole 1518 includes first andsecond extension portions 1520, 1524 extending from an anterior portionthereof.

Projections 1522 extend from the anterior surface of the first extensionportion 1520 for selective engagement with the receiving openings 1514of the dorsal shell 1490 and with receiving openings 1526 formed in thesecond extension portion 1524.

This configuration provides additional assurance that the projections1522 will not accidentally disengage from the receiving openings 1514 inthe dorsal shell 1510, by providing the second extension portion 1524covering the receiving openings 1514.

In an alternate configuration of the hinge shown in FIG. 52, the hingeshown in FIG. 53 includes an outsole (or plantar shell portion) 1530having first and second extension portions 1532, 1538 extending from ananterior portion thereof. Each of the first and second extensionportions 1532, 1538 includes at least one projection 1534, 1542extending therefrom and at least one receiving opening 1536, 1540 formedtherein. The projections 1534, 1542 are respectively formed on theanterior and posterior surfaces of the first and second extensionportions 1532, 1538.

The dorsal shell (not shown, see FIG. 52) includes a plurality ofreceiving openings. As will be understood, the receiving openings of thedorsal shell are sandwiched between the projections 1534, 1542 andreceiving openings 1536, 1540 of the first and second extension portions1532, 1538, such that the projections 1534, 1542 extend through thereceiving openings in the dorsal shell to retain the dorsal shell inconnection with the posterior shell.

This configuration provides yet another mechanism to ensure that thedorsal shell does not accidentally disengage from the posterior shell ofthe walker.

Various other hinge configurations that allow selective adjustment ofthe spacing between the dorsal shell and the posterior shell can beprovided to accommodate swelling and different size anatomies.

I. Variation of a Circumferential Walker

As shown in FIGS. 54-63, a variation of a circumferential walker 2100 isconfigured in an essentially two-piece construction to provide alightweight, sleek, and low profile device for use in stabilizing,immobilizing, and supporting the lower leg. Numerous advantages areobtained from such a configuration, as discussed above.

The walker 2100 includes a semi-rigid, or substantially rigid shellconfiguration as previously described. The walker 2100 includes aposterior shell 2120 that extends from a posterior side of the lower legand ankle, along the distal surface of the foot, and terminates in aplantar shell portion 2144 that extends along the plantar surface of thefoot. The posterior shell 2120 includes lateral and medial (first andsecond) wing portions 2122 that extend partially around the lower leg,ankle, and foot from the posterior shell 2120 to wrap around the leg inorder to at least partially enclose and support the lower leg.

A dorsal shell 2102 is generally complementary shaped to the posteriorshell 2120 to at least partially surround or enclose the lower leg,ankle, and foot to provide protection, support, and stabilizationthereto. The walker 2100 can thus be formed in a general configurationto fully encase and protect the lower leg, ankle, and foot.

As best seen in FIGS. 54, 55, and 60, the dorsal shell 2102 is formedeither in a single piece or in multiple shell portions. The dorsal shellcan include a raised reinforcing ridge 2110 running along the proximalsurface thereof and may also include clearance holes 2112 in accordancewith the discussion above. The dorsal shell 2102 also includes a pumpassembly receiving opening 2106 which can be configured in a similarmanner as previously discussed, or may simply be provided as a clearanceopening through the dorsal shell 2102. The position of the pump assemblyreceiving opening 2106 can be varied to accommodate numerous locations apump assembly.

In the exemplary embodiment, the dorsal shell 2102 includes a proximalshell portion 2104 that is connected to a distal shell portion 2108 viaa flexible or resilient portion or hinge connection 2114.

The connecting portion 2114 may be formed as a flexible or resilientmaterial positioned between the proximal and distal shell portions 2104,2108 and encompassing a connecting shell portion between the proximaland distal shell portions 2104, 2108. This connecting portion may beformed via overmolding a different material over the connecting shellportion to form a flexible or resilient expansion portion or mechanism,in a manner discussed above. The connecting portion 2114 can bepositioned so as to be located between the anatomical portion of thewearer and a strap used to retain the walker 2100 thereon. In thismanner, the possibility of pressure points being caused by such a strapis greatly reduced or eliminated.

The connecting portion 2114 can include holes 2216 passing therethrough,which may function as ventilation holes and/or which may increase theflexibility of the connecting portion 2114.

As best seen in FIG. 60, the connecting portion 2114 can include a gap2118 formed along one surface thereof. The presence of the gap 2118 willhelp to reduce or eliminate the formation of a pressure point along thedorsal surface of a user's lower leg, ankle, or foot. Further, due tothe flexible nature or resiliency of the connecting portion 2114, andthe additional presence of the gap 2118, when the dorsal shell 2102 isclosed around the user's lower leg, ankle, or foot, different sizedanatomies can be accommodated using the same sized walker 2100.Additionally, the walker 2100 will automatically expand or contract dueto swelling or reduction of swelling of the lower leg, ankle, and footof a user. Of course, it will be recognized that the gap 2118 is not arequired feature, and the connecting portion 2114 can accomplish theabove functions without the use of such a gap.

As best seen in FIGS. 54-59, the posterior shell 2120 has generally thesame configuration as discussed above, including clearance holes 2134,and reinforcing or strengthening structures 2142. Such reinforcing orstrengthening structures 2142 can extend over a portion of the height ofthe posterior shell 2120, as shown in FIG. 59, or over substantially theentire height of the posterior shell 2120. Also, as previouslydiscussed, the posterior shell 2120 can include a flexible or compliantproximal edge 2124, which can be overmolded. A portion of the flexibleor compliant edge 2124 can also be trimmed to accommodate users havingshorter legs, in order to avoid the creation of pressure points from theedge being too large. This allows the user to adjust the fit of thewalker 2100, without the creation of hard edges.

As best seen in FIGS. 55, 56, and 59, strap slots 2136 are positioned inthe proximal portion of the posterior shell 2120 for receiving a strap2140 therein. The strap 2140 can include suitable connecting structures,for example corresponding hook and loop fasteners at respective endsthereof so that the ends of the strap can be connected to each other. Ina variation, a loop or D-ring can be attached at one end of the strap2140 so that the strap can be looped through the loop or D-ring andattached to itself via suitable fasteners. Strap connecting portions2138, such as reduced thickness portions and/or holes for rivetconnections are also provided in the posterior shell wings 2122 toselectively anchor and retain strap assemblies. If holes and rivetconnections are used, then the connection points for the straps arepivotable and can allow some rotation or adjustability of the straps. Inthis variation, two sets of strap connecting portions 2138 arepositioned in the posterior shell wings 2122 so that two straps can beused to tighten and close the walker. It will be recognized that anydesired number of sets of strap connecting portions can be provided toaccommodate any desired number of straps. For example, loops or D-ringscan be attached, for example via loops of fabric, to the strapconnecting portions 2138 at both lateral and medial sides, along with astrap 2140 connected at one end to the strap connecting portion 2138.The other end of the strap 2140 can be looped through one or both of theloops or D-rings and connected to itself via suitable fasteners, such ashook and loop fasteners.

For ease of simplicity, a strap configuration is shown in FIG. 56,without the dorsal shell 2102 present. It can be seen that the ends ofthe straps 2140 can be attached at the anterior portion of the walker2100. Since the Straps 2140 are positioned at the front of the walker2100 this configuration allows easier access to the straps 2140 to allowwearers to adjust the fit of the walker 2100. The ends of the straps canbe connected in any suitable manner, such as hook and loop, or snapfasteners.

It will be recognized that, in use, the straps 2140 are disengaged andthe dorsal shell 2102, which is positioned under the straps when thewalker 2100 is worn, is removed to allow the wearer to place the lowerleg, ankle, and foot within an interior space defined among the dorsalshell 2102, the posterior shell 2120, and the plantar shell portion2144. Once the anatomical portion of the wearer is positioned within theinterior space, the dorsal shell 2102 can be positioned along the dorsalsurfaces of the lower leg, ankle, and foot and the straps 2140 can beengaged over the dorsal shell 2102 to retain the dorsal shell in placeto provide the desired amount of support and stabilization to the lowerleg, ankle, and foot. It will be recognized that other suitableattachment mechanisms, such as quick connect strapping mechanismsdiscussed herein, can be used to secure the dorsal shell 2102 in place.

As best seen in FIGS. 55 and 57-59, the plantar shell portion 2144includes reinforcing, connecting, or guide ridges 2146 positioned alongthe distal surface thereof for guiding placement of and/or providingconnection for an outsole 2148. Additionally, reinforcing ribs orstructures can be provided along the proximal surface of the plantarshell portion 2144 if needed. The outsole 2148 can be formed in anymanner previously discussed, either as a separate element or integrallywith the plantar shell portion 2144. The outsole 2148 can include a heelprotector 2154 and a toe protector portion 2150 that is configured tocover and protect the toes of a wearer when the walker 2100 is worn.However, if necessary to accommodate larger sized anatomies, or toaccommodate swollen toes, the toe protector portion 2150 can be trimmeddown or trimmed completely away.

As best seen in FIG. 55, the outsole 2148 can also include cushioningstructures 2152 formed therein to provide appropriate biomechanicalfunctions. In particular, the cushioning structures 2152 can beconfigured to adjust heel strike and rollover properties of the walker2100. The outsole 2148 can be formed as a full rocker bottom to providethe associated benefits to the wearer's gait.

Returning to the posterior shell 2120, as best shown in FIGS. 57-59,additional expansion mechanisms are formed in the posterior shell 2120to reduce or eliminate pressure points and to accommodate users havingdifferent sizes of lower legs, ankles, and feet. As previouslydiscussed, a flexible or resilient edge 2124 can be formed along theedges of the posterior shell 2120 of the wing portions 2122 toaccommodate different sized anatomical portions of different wearers.

Additionally, expansion joints 2126 can be provided between a posteriorportion of the posterior shell 2120 and the posterior shell wings 2122.The expansion joints 2126 can be similarly formed and function in amanner as discussed above. The expansion joints 2126 allow the posteriorshell 2120 to automatically stretch or compress to accommodate differentsized wearers.

In particular, the expansion joints 2126 can be formed having a largerdimension at the proximal end and tapering down to a smaller dimensionat the distal end. In a variation from previously discussed expansionjoints, the expansion joints 2126 can include a bridge 2130 spanningacross the expansion joint 2126, although such a bridge is notnecessary. The function of the bridge 2130 will be discussed in moredetail below.

The expansion joints 2126 can be overmolded as previously discussed andcan includes a number (any desired) of expansion holes 2128 passingtherethrough that can be arranged in any suitable manner. The expansionholes 2128 can have any desired shape or size and can also act as vents.Additionally, the overmolded sections between the expansion holes 2128can be thinner than the overmolded portions that contact the edges ofthe posterior shell and wing portions 2120, 2122. The reduced thicknesssections can thus allow easier stretching of the expansion joints 2126.

Due to the resiliency or flexibility thereof, the expansion joints 2126allow the posterior shell wing portions 2122 to expand away from eachother or contract towards each other in order to accommodate swelling ordifferent sized anatomies, such as larger or smaller calves, and canreduce or eliminate pressure points. Thus, the walker 2100 canaccommodate swelling of the limb or users having different sized calves,without losing rigidity in the sagittal plane (the plane dividing thewalker 2100 into medial and lateral sides). Due to the larger proximalend, the expansion joint allows more expansion between the proximalportions of the wing portions 2122 than at distally spaced positions ofthe wing portions 2122.

If greater expansion is necessary, for example, in order to accommodateeven larger calf sizes, the overmolded portion of the expansion joints2126 can be cut or torn to allow the wing portions 2122 to be able tomove further from the posterior portion of the posterior shell 2120. Dueto the flexibility or compliance of the overmolded portion of theexpansion joints 2126, this portion is relatively easy to cut or tear,and does not leave sharp edges that can cause injury.

In the case that the overmolded portion of the expansion joints 2126 isto be cut or torn, the expansion holes 2128 can act as stopping pointsfor the cut or tear, so that the cut or tear does not extend furtherthan is desired. In this manner, incremental adjustments can beachieved. The cutting or tearing of the overmolded portion of theexpansion joints 2126 can extend all the way to the bridge 2130positioned in the expansion joint 2126, and the bridge 2130 can then actas a stopping point.

As best seen in FIGS. 55 and 59, overmolding 2132 can be provided on thebridge 2130 in the interior space of the walker 2100. If even moreexpansion is needed, the bridge 2130 can be cut or broken, and theovermolding 2132 serves the function of preventing sharp edges from thecut or broken bridge 2130. The bridge 2130 can include a weakened orfrangible portion to aid with cutting or breaking the bridge, in amanner that will be recognized by a skilled artisan.

If even more expansion is needed, the expansion holes 2128 positionedbelow the bridge 2130 can also be cut, similarly as discussed above. Inthis manner, there is a large amount of adjustability provided in thewalker 2100, such that many wearers having different sizes and shapes ofanatomical portions can utilize a generally one size fits all walker.

To further provide a generally one size fits all walker, as shown inFIG. 63, a liner 2172 having inflatable bladders and foam padding can beprovided as an interface between the wearer's anatomy and the walker2100. It will be recognized that additional cushioning, such as providedby insoles or separate heel cushions positioned behind the Achillestendon, can also be provided. The liner 2172 can have any suitableconfiguration, such as any of those previously discussed, includinglinked medial and lateral bladders. The liner 2712 can include acovering material, such as softgood, that can be used to engage hookfasteners positioned on opposed flaps thereof, such that the liner 2172cane be positioned and secured to the lower leg, ankle, and foot of thewearer. Additional perspiration wicking material 2178 cane be positionedon or in the liner 2172. The liner 2172 can also include a strategicallyplaced spacer element 2176 that can aid with heat and moisturedissipation. For example, the spacer element 2176 can be positionedalong the dorsal aspect of the liner 2174 above the foot of the wearer.

As discussed above, the liner 2172 can include inflatable bladders,which can be inflated or deflated to accommodate different sizedanatomies or to accommodate swelling, and to provide a desired amount ofsupport and stabilization to the lower leg, ankle, and foot. Thebladders can be inflated via an inflation tube, which is connected to apump assembly 2156.

As shown in FIG. 63, the pump assembly 2156 is connected to theinflation tube, and is carried by the liner 2172. The liner 2172includes a sliding slot 2174 through which the inflation tube canslightly extend. In this manner, the pump assembly 2156 can be slid inthe lateral-medial direction. When the liner 2172 is placed within theinterior space of the posterior shell 2120, and secured about thewearer's anatomy, the pump assembly 2156 can thus be slid in thelateral-medial direction in order to aid with aligning the pump assembly2156 with the pump assembly receiving opening 2106 in the dorsal shell2102. Thus, donning of the walker 2100 is made easier.

As shown in FIGS. 61 and 62, the pump assembly 2156 includes an assemblycover 2158, which is made from any suitable flexible, resilient, orcompliant material, and which covers the pump 2164 and release valve2170 assemblies. The assembly cover 2158 includes vent openings 2160 toallow air vented from deflating the bladders to pass through theassembly cover 2158 to atmosphere. The assembly cover 2158 can alsoinclude actuation enhancement features 2162, such as raised portions orridges, which may be configured in any suitable design, such as a crossor an elongated portion. The actuation enhancement features 2162 providefeatures to enhance function or gripping for allowing the user to moreeasily actuate the pump 2164 and the release valve 2170.

As best shown in FIG. 62, the pump assembly 2156 is similarly configuredto the pump assembly previously discussed, and includes an inlet valve2166, which may be a one-way valve that can also function as a releasevalve, positioned at one end of the pump 2164, which may be a diaphragmpump, and a one-way outlet valve 2168 positioned at a second end of thepump 2164. The one-way outlet valve 2168 communicates through therelease valve 2170, which can be of any suitable type, including therelease valve previously discussed, with the bladder inflation tube forinflating the bladders. The remaining features of the pump assembly 2156function in a similar manner as discussed above.

Once the liner 2172 is positioned about and secured to the lower leg,and is positioned within the walker 2100, the pump 2164 can be actuatedto inflate the bladders therein to provide an appropriate amount ofcompression, support, and stability to the lower leg, ankle, and foot.

In view of the above discussed embodiments, it can be seen that a highlyadjustable circumferential walker is disclosed, which can accommodate alarge variation of sizes of anatomies or swelling of the anatomicalportions.

J. Conclusion

The disclosed embodiments of a circumferential walker provide manyimprovements and allow easy insertion or removal of the lower leg intothe walker. Additionally, the quick connect strap tightening mechanismsallow quick and easy tightening of the walker around the lower leg inorder to provide the necessary support and stabilization of the lowerleg, ankle, and foot. Accordingly, the disclosed embodiments of acircumferential walker are easier to don and doff, which will beadvantageous to numerous users, including the elderly or infirm.

It is understood that the size of the disclosed embodiments and thecomponents thereof can be adjusted so that different users havingdifferent sized legs, ankles, and feet may benefit from the presentdesign. Specifically, the width, thickness and length of the shells andsole members may be varied to accommodate different sized users.

It is also understood that the locations and numbers of the variousstraps and connection points can be alternated from those shown, suchthat the number of straps and connection points, and their respectivepositions may be altered from the numbers and positions as illustratedherein.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features from the disclosed embodiments and variations. Forexample different connecting mechanisms may be freely changed andsubstituted. Additionally, any suitable tightening mechanism may beutilized, such as lacing or hook and loop strap fasteners. In additionto the variations described herein, other known equivalents for eachfeature can be mixed and matched by one of ordinary skill in this art toconstruct a circumferential walker in accordance with principles of thepresent invention.

Although this invention has been disclosed in the context of exemplaryembodiments and examples, it therefore will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

1. An orthopedic device comprising: a first member contoured togenerally correspond to an anatomical limb; a second member contoured togenerally correspond to an anatomical limb and corresponding to thefirst member; and at least one expansion mechanism positioned on thefirst or second member and configured to accommodate changes inanatomical limb size due to an increase or decrease in swelling and/orto accommodate different sized anatomical limbs of various users.
 2. Theorthopedic device according to claim 1, wherein the at least oneexpansion mechanism is formed between first and second wing portions ofthe first member to allow the first and second wing portions to moverelative to each other.
 3. The orthopedic device according to claim 2,wherein the at least one expansion mechanism comprises: an openingformed between the first and second wing portions; a frangible orcuttable bridge portion spanning the opening; and a flexible overmoldedportion formed within the opening and along the bridge portion.
 4. Theorthopedic device according to claim 1, wherein the at least oneexpansion mechanism is formed between a wing portion and a posteriorportion of the first member to allow the wing and posterior portions tomove relative to each other.
 5. The orthopedic device according to claim4, wherein the at least one expansion mechanism comprises: an openingformed between the wing and posterior portions; a frangible or cuttablebridge portion spanning the opening; and a flexible overmolded portionformed within the opening and along the bridge portion.
 6. Theorthopedic device according to claim 1, wherein the at least oneexpansion mechanism is formed along an edge of the first member.
 7. Theorthopedic device according to claim 6, wherein the at least oneexpansion mechanism is a flexible edge overmold.
 8. The orthopedicdevice according to claim 1, wherein the at least one expansionmechanism is formed between first and second portions of the secondmember.
 9. The orthopedic device according to claim 1, wherein the atleast one expansion mechanism is formed along an edge of the secondmember.
 10. The orthopedic device according to claim 9, wherein the atleast one expansion mechanism is a flexible edge overmold.
 11. Theorthopedic device according to claim 9, wherein the at least oneexpansion mechanism is a living hinge.
 12. The orthopedic deviceaccording to claim 1, further comprising: an outsole along the firstmember; and at least one tightening strap connected to the first memberand extending over the second member to secure the first and secondmembers together about an anatomical limb.
 13. The orthopedic deviceaccording to claim 1, wherein the first and second members include aplurality of clearance openings formed therein and the first and secondmembers include at least one reinforcing structure.
 14. The orthopedicdevice according to claim 1, further comprising: a pump assemblyconfigured for integration with at least one of the first and secondmember; and at least one bladder arranged along an inner surface of atleast one of the first and second member.
 15. The orthopedic deviceaccording to claim 14, wherein the at least one bladder is in the formof a medial and a lateral bladder connected together for simultaneousinflation or deflation.
 16. The orthopedic device according to claim 14,wherein the at least one bladder includes a channel formed therein forproviding heat and/or perspiration dissipation.
 17. The orthopedicdevice according to claim 14, wherein the at least one bladder includesan opening formed therein for providing a vent for heat and/orperspiration dissipation.
 18. The orthopedic device according to claim14, wherein the at least one bladder includes an inflation tube, thebladder and inflation tube carried within a liner; the liner includes aslot formed therein, the inflation tube passing through the slot andrelatively moveable within the slot with respect to the liner; and thepump assembly is connected to the inflation tube relatively moveablewith respect to the liner for positioning within a receiving openingformed in the second member.
 19. An orthopedic device comprising: afirst member contoured to generally correspond to an anatomical limb; asecond member contoured to generally correspond to an anatomical limband corresponding to the first member; at least one opening formed inthe first member; a frangible or cuttable bridge portion spanning theopening; and a flexible overmolded portion formed within the opening andalong the bridge portion and configured to accommodate changes inanatomical limb size due to an increase or decrease in swelling and/orto accommodate different sized anatomical limbs of various users.
 20. Anorthopedic device comprising: a first member contoured to generallycorrespond to an anatomical limb; a second member contoured to generallycorrespond to an anatomical limb and corresponding to the first member;at least one expansion mechanism positioned on the first or secondmember and configured to accommodate changes in anatomical limb size dueto an increase or decrease in swelling and/or to accommodate differentsized anatomical limbs of various users; and a liner having at least oneinflatable bladder, the liner received between the first and secondmembers and carrying a pump assembly configured to be received in areceiving opening formed in the second member.